| 基本情報/Basic information |
| 一般向け試験名/Public title |
高齢者における進行期中高悪性度非ホジキンリンパ腫にに対するTHP-COP療法の第II相試験 |
A multicenter, phase II study of full-dose THP-COP therapy for elderly patients with newly diagnosed, advanced-stage, aggressive non-Hodgkin lymphoma |
| 一般向け試験名略称/Acronym |
THP-1 |
THP-1 |
| 科学的試験名/Scientific Title |
高齢者における進行期中高悪性度非ホジキンリンパ腫にに対するTHP-COP療法の第II相試験 |
A multicenter, phase II study of full-dose THP-COP therapy for elderly patients with newly diagnosed, advanced-stage, aggressive non-Hodgkin lymphoma |
| 科学的試験名略称/Scientific Title:Acronym |
THP-1 |
THP-1 |
| 試験実施地域/Region |
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| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
THP 50-mg/m2, CPA 750 mg/m2, VCR 1.4mg/m2 (max 2.0 mg/body)をday 1に静注, PDN100mg/body をdays 1から5に内服し、3週毎、6コースまで繰り返す。 |
For THP-COP therapy, 50mg/m2 THP, 750 mg/m2 CPA, and 1.4mg/m2 VCR (max 2.0 mg/body) were administered on day 1, and 100mg/body PDN was administered on days 1~5 in accordance with the CHOP regimen regulations. This regimen was administered every 3 weeks for up to six courses. If the THP dose was decreased due to toxicity, up to two courses of additional treatment were administered to permit the cumulative dose of THP to reach 300 mg/m2. |
| 介入2/Interventions/Control_2 |
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| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
・年齢：70-79歳
・前治療がない
・WF分類のD, E, F, G, H, J
・AnnArbor分類のbulky I期、II-IV期
・PS 0-1
・好中球数 >1200/μl
・血小板数 > 5万/μl
・AST、ALTが正常上限の5倍未満
・総ビリルビン < 2.0mg/dl
・クレアチニン < 2.0mg/dl
・EF > 50%
・PaO2 > 60 torr |
70 to 79 years of age, previously untreated, Working Formulation D through H and J , clinical stage I disease with a bulky mass or stage II,III,IV disease according to the Ann Arbor classification , Eastern Cooperative Oncology Group performance status of 0,1 |
| 除外基準/Key exclusion criteria |
重複がん、性心疾患、心筋梗塞または狭心症の既往、中枢神経浸潤、コントロール不良の糖尿病、HIV陽性、HBs抗原陽性、HCV陽性 |
any other malignancies, mental illness, myocardial infarction or angina history, central nervous system infiltration, uncontrollable diabetes, human immunodeficiency virus infection, hepatitis B virus surface antigen, and/or hepatitis C virus antibody positivity were excluded. |
| 目標参加者数/Target sample size |
27 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
http://www.hmcsg.umin.jp/ |
| 組み入れ参加者数/Number of participants that the trial has enrolled |
30 |
| 主な結果/Results |
CR割合：65.5％
3年FFS：54.1％
3年OS：53.9％ |
The CR rate was 65.5% (95% confidence interval, 45.7~82.1%). The 3-year failure-free and overall survival rates were 54.1% and 53.9%, respectively. |
| 主な結果入力日/Results date posted |
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| 結果掲載遅延/Results Delayed |
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| 結果遅延理由/Results Delay Reason |
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| 最初の試験結果の出版日/Date of the first journal publication of results |
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| 参加者背景/Baseline Characteristics |
年齢中央値72歳
PS 0：46.7％
DLBCL：63.3％
CS II：53.3％、III,IV：46.7％
IPI L, LI：60.0％、HI：40.0％ |
The age of the registered patients ranged from 70 to 79 years old, with a median of 72 years old. Out of the 30 patients in total, 20 (65.5%) patients were 70~74 years of age, and 10 (34.5%) were 75~79 years of age. Fourteen patients (46.7%) were PS 0, and 16 patients (53.3%) were PS 1. Regarding histopathological type, 19 patients (63.3%) had diffuse large B-cell lymphoma (DLBCL). Regarding the clinical stage, 16 (53.3%) patients had stage II disease, 14 (46.7%) had stage III~IV disease, and three patients (10.0%) had a bulky mass. When the 29 eligible patients were stratified into four groups on the IPI basis, 8 patients (26.7%) were in the low-risk group, 10 patients (33.3%) were in the low-intermediate-risk group, 12 patients (40.0%) were in the high-intermediate-risk group, and no patient was in the high-risk group. |
| 参加者の流れ/Participant flow |
1999年1月から2000年6月まで30人が登録 |
A total of 30 patients (19 males and 11 females) from 6 hospitals belonging to the Hematological Malignancy Clinical Study Group (HMCSG) were registered between January 1999 and June 2000. |
| 有害事象/Adverse events |
Grade 3以上の好中球減少は80％に認められた。
Grade 3の心毒性は1人であった。 |
The most frequent observed grade 3 or 4 toxicity was neutropenia, which occurred in 80% of the patients. Grade 3 cardiac dysfunction was observed in one patient. |
| 評価項目/Outcome measures |
プライマリーエンドポイントは、統計学的仮説を満たした。 |
primary endpoint was met |
| 個別症例データ共有計画/Plan to share IPD |
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| 個別症例データ共有計画の詳細/IPD sharing Plan description |
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UMIN-CTR 臨床試験登録情報の閲覧